Comparison Between Volatile Anesthetic-desflurane and Total Intravenous Anesthesia With Propofol and Remifentanil on Early Recovery Quality and Long Term Prognosis of Patients Undergoing Pancreatic Cancer and Common Bile Duct Cancer Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- score of QoR40 (Quality of Recovery 40)
研究概览
简要总结
Investigators asses whether there is any difference in short term recovery and long term prognosis according to the anesthetic method in patients who undergoing pancreatic cancer and bile duct cancer and undergoing surgery for PPPD or distal pancreatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
- The investigator who research the QoR-40 questionnaire before and after the surgery will not know which group the patient is assigned to.
- Because of the difference in anesthesia method, it is impossible to apply blindness to an anesthesiologist practicing anesthesia. Thus, the anesthesiologist will maintain anesthesia with the same target in both groups. (anesthesia depth, hemodynamic status and pain control)
- Blind is released to investigator and outcomes assessor after completion of QoR-40 questionnaire.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ASA class I-III who are scheduled to undergo general anesthesia and who are diagnosed with pancreatic cancer or common bile duct cancer and who are scheduled for PPPD or distal pancreatectomy
- •patients who voluntarily agree to participate the clinical study after fully informed and understood about the study
排除标准
- •there was distant metastasis at the time of diagnosis
- •history of drug adverse reaction or use of opioid or sedative drugs before the surgery
- •patients who can not communicate enough to answer the survey
- •obesity patients over BMI 30
- •patient who are expected to maintain ventilator care on the first day of post operation due to the difficult to extubation right after the surgery
- •patients who have inappropriate reasons to participate in clinical research
研究组 & 干预措施
DES Group
Desflurane will be administered via tracheal intubation tube at the level of 0.7-1.1 MAC. Remifentanil will be maintained intravenously by continuous infusion rate of 0.01-0.1 mcg / kg / min
DES Group's anesthetic depth will be adjusted to maintain the BIS (Bispectral index) between 40-60. Vital sign will be maintained within the range of ± 20% of the baseline MBP (Mean BP) and HR (Heart Rate).
干预措施: Des (volatile anesthetic-desflurane) (Drug)
TIVA Group
Propofol and remifentanil will be administered via intravenous, using an infusion pump capable of effect site target controlled infusion.
TIVA Group's anesthetic depth will be adjusted to maintain the BIS (Bispectral index) between 40-60. Vital sign will be maintained within the range of ± 20% of the baseline MBP (Mean BP) and HR (Heart Rate).
干预措施: TIVA (Total intravenous anesthesia with propofol and remifentanil) (Drug)
结局指标
主要结局
score of QoR40 (Quality of Recovery 40)
时间窗: post operative day #3
The QoR-40 consists of a total of 40 questionnaires divided into five categories, it is considered to be the most appropriate index to measure the patient's integrated post operation recovery. Our primary outcome is the score of QoR-40 on the third day after surgery
次要结局
- score of QoR40 (Quality of Recovery 40)(post operative day #7)